NIR and Skin Cancer Margins

NCT ID: NCT04103658

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2019-12-30

Brief Summary

We aim to determine whether the application of near-infrared radiation via standard heat lamp to non-melanoma skin lesions (such as basal cell carcinomas) before surgical excision is able to better delineate the lesion and surgical margins. If found to do so, pre-heating of skin lesions could lead to more specimens with negative margins. Patients presenting to the tertiary care centre skin cancer clinic for excision of skin cancer will be approached and offered to participate in the study.

Detailed Description

Non-melanoma skin cancer (NMSC) is the most common cancer diagnosis in Canada, and its incidence is still increasing. Visual examination followed by biopsies of suspicious lesions are the gold standard for skin cancer diagnosis. The mainstays of treatment include photodynamic therapy, radiation therapy, and surgical excision. The margins of NMSC lesions are typically determined via visual inspection, and excised based on delineating normal from abnormal tissue. According to the National Comprehensive Cancer Network, low-risk basal cell cancers should be excised with a 4mm margin; squamous cell skin cancers and high-risk basal cell cancers should be excised with 4-6mm margins, as per the National Comprehensive Cancer Network. These lesions frequently occur on cosmetically sensitive areas of the head and neck, therefore accurate margins and excision can help to preserve the overall appearance. Accurate lesion delineation with proper margins can also reduce the need for further treatment if the margins are positive. In approximately 2-3% of cases at our centre, the margins are positive.

Near-infrared radiation (NIR) represents the light spectrum from 0.7 to 1.5 micrometers. At the shorter wavelengths, it merges with the red spectrum of visible light. These forms of light have the ability to heat the skin up to a 5 mm depth. Previous studies have examined the relationship between skin blood flow and temperature when heating skin, where dermal temperature can reach a certain peak in a defined time. Other studies have investigated the application of NIR when combined with photo immunotherapy, as a means of treating other cancers. More elaborate multispectral analysis devices have been studied for their effectiveness in diagnosing cutaneous malignancies. NIR application is well tolerated, in past studies.The objective of this study is to determine if the vasculature of normal skin and NMSC skin appears differently following heating with NIR light, and if this difference corresponds to better margin delineation.

The excisions and reconstructions are all within the standard of care. The only added testing will be application of near-infrared heat via a heating lamp to the lesional skin, for a total of ten minutes. Each patient will have their skin cancer lesion photographed, and traced onto acetate film. The NIR heating will then occur under a lamp for a total of ten minutes at a distance of 20cm. At the end of the ten minutes, the lesion and its borders will again be traced onto a separate acetate film. Using Excel for block randomization, patients will then be randomized to excision with the non-heated versus heated margins. The allocation will not be known until the moment of assignment. The excisions will then occur in the same fashion between the two groups, and all specimens will be submitted for pathology, as is standard of care.

Data will be recorded for various patient and lesions factors that may potentially influence the outcome of NIR heating therapy. These include age and gender, lesion size and location, and history of skin disorders. The lesion size and final pathology, with quantitative margin distances, will be recorded. Statistical analysis will be performed to determine if there is an overall difference in qualitative (negative or positive) and quantitative margin status between those lesions excised under standard procedure vs. NIR heating.

Conditions

Non-melanoma Skin Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care (control)

This will be the standard of care group. The excision of the non-melanoma skin cancer will be based on standard visual inspection with 4-6mm margins.

Group Type: NO_INTERVENTION

No interventions assigned to this group

NIR heating

This will be the NIR heating group, where the excision of the non-melanoma skin cancer will be based on the lesion margins based on the application of near-infrared radiation (with 4-6mm margins).

Group Type: EXPERIMENTAL

Near-infrared heating

Intervention Type: RADIATION

Same as the arm/group description. The NIR heating group will have the non-melanoma skin cancer lesion excised based on the lesion borders established from application of NIR heat at a distance of 20cm for 10 minutes.

Interventions

Near-infrared heating

Same as the arm/group description. The NIR heating group will have the non-melanoma skin cancer lesion excised based on the lesion borders established from application of NIR heat at a distance of 20cm for 10 minutes.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

The patient population includes individuals with a nonmelanotic cervicofacial cutaneous malignancy referred to a tertiary care skin cancer clinic for definitive treatment. Patients must have:

• Histologically confirmed nonmelanotic cutaneous malignancies, either basal cell or squamous cell carcinoma
• No prior treatment with investigational agents
• Ability to tolerate intended treatment Patient's age is greater than or equal to 18 years

Exclusion Criteria

• Prior radiation therapy or photodynamic therapy to the area with the NMSC lesion
• Patients with a history of cutaneous photosensitization
• Unable to consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Kiersten Pianosi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Kiersten Pianosi, MD

Role: CONTACT

kpianosi@uwo.ca

519-685-8500 ext. 18074

Corey Moore, MD

Role: CONTACT

corey.moore@sjhc.london.on.ca

519-685-8500 ext. 66383

Other Identifiers

114153

Identifier Type: -

Identifier Source: org_study_id